28 Apr Pushing the envelope without breaking the seal

Creating promotions that are on target, on strategy, on message, on budget, and on time is challenging. Ensuring that the promotions also comply with the guidelines of the FDA and other regulatory bodies adds a whole other layer of challenges.

In 2013, the FDA sent well over a dozen warning letters to pharmaceutical marketers regarding problems with their promotions, usually claims without sufficient substantiation or fair balance. In 2014, the FDA was on pace to issue more than a dozen warnings again. The violators range from industry leaders to up-and-comers. Each warning letter, along with a PDF of the offending promotion, is posted on the FDA website.
In some cases, the problem may be purely unintentional, stemming from ignorance or misinterpretation of the regulations, or just poor oversight of the content development process. In other cases, a company may have been trying to push the envelope with their promotions and simply pushed too far.

Knowing how far you can go – how to articulate, illustrate, and substantiate compelling messaging for a brand, while adhering to FDA guidelines – combines art and science. The science part entails understanding what you can say, when, and where – the science of the product you’re promoting, as well as the “science” of federal regulations. The art part of the quotient entails making the promotion uniquely creative.

Beyond maintaining this critical science-art balance, a regulatory-sensitive agency should fulfill three more requirements:

Have a proven process for substantiating content, documenting the substantiation, and archiving the documentation. This should be a well-organized, consistent process that all agency personnel adhere to.

Be able to participate in rigorous content review, such as the notorious “black folder” sessions at many companies, where representatives from the organization’s medical, legal, regulatory, and marketing departments dissect communication campaigns word by word, often requiring on-label solutions on the fly.

Maintain an unwavering sense of responsibility and vigilance. An experienced, savvy agency understands full well the consequences of being careless when it comes to creating regulatory-sensitive content. They maintain the highest standards and stay aware of changes as regulations evolve.

When a company and its healthcare marketing agency collaborate, the goal is to push the envelope – to create edgy, memorable promotions – without breaking the seal: the seal of trust between the company and the FDA, between the company and its target audiences…and between the company and the healthcare marketing agency.